| CTRI Number |
CTRI/2024/02/063042 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A STUDY TO COMPARE INTERATHECAL ROPIVACAINE HEAVY 0.75% AND BUPIVACAINE HEAVY
0.5 % IN ORTHOPAEDIC SURGERIES. |
|
Scientific Title of Study
|
A PROSPECTIVE RANDOMISED DOUBLE BLIND CONTROLLED STUDY TO COMPARE INTERATHECAL ROPIVACAINE HEAVY AND BUPIVACAINE HEAVY IN ORTHOPAEDIC SURGERIES. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Dolly Sorout |
| Designation |
PG Resident Department of Anaesthesiology |
| Affiliation |
Pacific medical college and hospital |
| Address |
Pacific medical college and hospital, Department of Anaesthesiology Udaipur, Rajasthan
313001
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9671828047 |
| Fax |
|
| Email |
Soroutdolly0493@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. R.K Singh |
| Designation |
Professor Department of Anaesthesia |
| Affiliation |
Pacific medical college and hospital |
| Address |
Pacific medical college and hospital Udaipur, Rajasthan
313001
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9166077724 |
| Fax |
|
| Email |
singhdrrk@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Dolly Sorout |
| Designation |
PG Resident (Department of Anaesthesia |
| Affiliation |
Pacific medical college and hospital |
| Address |
Pacific medical college and hospital, bheelo ka bedla, Udaipur, Rajasthan
313001
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9671828047 |
| Fax |
|
| Email |
Soroutdolly0493@gmail.com |
|
|
Source of Monetary or Material Support
|
| pacific medical college and hospital,udaipur |
|
|
Primary Sponsor
|
| Name |
Pacific medical college and hospital |
| Address |
Flat no 2, P2 building, Pacific medical college and hospital, bheelo ka bedla Udaipur |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR RK SINGH department of anaesthesia |
Pacific Medical College & Hospital, Udaipur |
Pacific medical college and hospital,department of anaesthesiology,bhillon ka bedla, udaipur, rajasthan 313001
Udaipur
RAJASTHAN |
9166077724
singhdrrk@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The instititional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M164||Bilateral post-traumatic osteoarthritis of hip, (2) ICD-10 Condition: M706||Trochanteric bursitis, (3) ICD-10 Condition: S723||Fracture of shaft of femur, (4) ICD-10 Condition: S730||Subluxation and dislocation of hip, (5) ICD-10 Condition: S818||Open wound of lower leg, (6) ICD-10 Condition: S822||Fracture of shaft of tibia, (7) ICD-10 Condition: S920||Fracture of calcaneus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Ropivacaine Heavy 0.75% 3.5 ml
|
injection Ropivacaine Heavy 0.75% 3.5 ml intrathecally in orthopaedics surgeries |
| Intervention |
injection bupivacaine 0.5% heavy 3.5 ml |
injection bupivacaine 0.5% heavy 3.5 ml in orthopaedics surgeries |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients of age groups between 20 to 60 years of either sex.
Patients belong to American Society of Anaesthesiologists (ASA) grade 1 and grade 2.
patients posted for lower limb surgeries. |
|
| ExclusionCriteria |
| Details |
1. ASA grade 3 and grade 4
2.congenital anomaly patient
3.Those with bleeding disorders and local sepsis
4.Patients refusal
5.Patients allergic to local anaesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration of analgesia
post operative analgesic requirement.
incidence of shivering. |
Duration of analgesia
post operative analgesic requirement.
incidence of shivering till 24hrs after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| duration of analgesia and requirement of rescue analgesia. |
24months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A study to compare efficacy, onset of block , duration of action ,haemodynamic stability of injection Ropivacaine 0.75% and injection Bupivacaine 0.5% intrathecally in Orthopaedics surgery |